A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01423318
First received: August 22, 2011
Last updated: April 7, 2014
Last verified: April 2014

August 22, 2011
April 7, 2014
August 2011
February 2012   (final data collection date for primary outcome measure)
  • Safety: Incidence of adverse events in healthy Japanese subjects [ Time Frame: 120 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics in healthy Japanese subjects: Area under the concentration-time curve (AUC) [ Time Frame: 120 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01423318 on ClinicalTrials.gov Archive Site
  • Comparison of safety (incidence of adverse events) in healthy Japanese and Caucasian subjects [ Time Frame: approximately 5 months ] [ Designated as safety issue: No ]
  • Comparison of pharmacokinetics (AUC) in healthy Japanese and Caucasian subjects [ Time Frame: approximately 5 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Lebrikizumab in Healthy Japanese and Caucasian Volunteers
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Doses of Lebrikizumab in Healthy Japanese and Caucasian Volunteers

This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the safety and pharmacokinetics of subcutaneous lebrikizumab in healthy Japanese volunteers. Healthy Japanese and Caucasian volunteers will be randomized to receive a single subcutaneous dose of either lebrikizumab or placebo.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy Volunteer
  • Drug: lebrikizumab
    Dose-level cohorts receiving single subcutaneous dose
  • Drug: placebo
    single dose subcutaneously
  • Experimental: A
    Intervention: Drug: lebrikizumab
  • Placebo Comparator: B
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
February 2012
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult healthy males and females, 18 to 55 years of age inclusive
  • Caucasian, Japanese, or non-Japanese subjects. Caucasian or non-Japanese subjects will have no parents or grandparents of Japanese descent; Japanese subjects must be first, second or third generation
  • Body weight between 45 and 105 kg, inclusive
  • In good health, determined by no clinically significant findings from medical history, 12-lead ECG, vital signs, and laboratory evaluations
  • Fertile males and women of childbearing potential must use appropriate form of contraception from screening until 60 days after study completion
  • Negative for hepatitis B, hepatitis C, and HIV infection
  • Negative for selected drugs of abuse at screening (not including alcohol) and at check-in (including alcohol)

Exclusion Criteria:

  • Pregnant and lactating women
  • History of clinically significant drug allergy and/or a known hypersensitivity to the study drug or formulation components
  • History of helminthic infection or travel within the past 3 months to areas of high risk for parasitic exposure
  • Use of prescription drugs including inhaled, oral, or parenteral corticosteroids and/or beta agonists, within 7 days prior to dosing or during the study
  • Use of tobacco- or nicotine-containing products from 7 days prior to check-in, resulting in urinary cotinine >500 ng/mL. Minimal/intermittent smoking will be permitted during the study
  • Participation in any other investigational drug trial in which receipt of an investigational study drug occurred within 30 days or 5 half-lives, whichever is longer, prior to check-in (Day -1)
  • History of significant, chronic, or recurrent infections requiring treatment
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01423318
GB25741
Not Provided
Genentech
Genentech
Not Provided
Study Director: Clinical Trials Genentech
Genentech
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP